Ignite Creation Date:
2024-05-06 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03590327
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2018-05-15
Brief Title:
Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAMCI
Brief Summary:
Apathy a profound loss of initiative and motivation is often seen in older Veterans with memory problems Apathy leads to serious health problems increases dependency and caregiver burden If untreated apathy hastens the progression to frank dementia In a pilot study the investigators found that apathy working memory and function can be restored using magnetic stimulation in some but not all older Veterans The reason for this variation is unknown The investigators propose a three-phase study in 125 older Veterans with mild memory problems Their motivation memory and function will be measured periodically Veterans with apathy that are eligible for treatment will receive either real or sham magnetic stimulation to the front part of their brain over 20 sessions Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not Impact on function quality of life and rates of progression to dementia will also be studied
A project modification was obtained to conduct a cross-sectional study the COVID Dementia study The cross-sectional study will examine the effect of the pandemic on MCI and AD patients and their caregivers individual COVID-related factors such as personally infected death of a friendfamily member economic hardship disruption in care isolation barriers to telehealth caregiver distress NPS cognition including onset of delirium and function Our goal is to develop a multi-pronged remotely deliverable intervention to address consequences of healthcare disruptions in older Veterans with cognitive impairment
Aim 1 To explore the association between COVID-related factors and neuropsychiatric symptoms in individuals with MCI and AD Hypothesis The number of COVID-related factors endorsed by caregivers will be positively correlated with the severity of NPI-Q in individuals with MCI and AD
Aim 2 To assess cognition telephonic version of the Montreal Cognitive Assessment tMoCA12 and daily function Functional Activities Questionnaire FAQ13 Hypothesis The number of COVID-related factors will be positively correlated with the severity of cognitive and functional deficits in individuals with MCI and AD
Aim 3 To explore the associations among COVID-related factors and caregiver distress Hypothesis Caregiver resilience and perceived social support will modify the association between COVID-related factors and severity of distress in caregivers
A project modification was obtained to conduct a cross-sectional study the COVID Dementia study The cross-sectional study will examine the effect of the pandemic on MCI and AD patients and their caregivers individual COVID-related factors such as personally infected death of a friendfamily member economic hardship disruption in care isolation barriers to telehealth caregiver distress NPS cognition including onset of delirium and function Our goal is to develop a multi-pronged remotely deliverable intervention to address consequences of healthcare disruptions in older Veterans with cognitive impairment
Aim 1 To explore the association between COVID-related factors and neuropsychiatric symptoms in individuals with MCI and AD Hypothesis The number of COVID-related factors endorsed by caregivers will be positively correlated with the severity of NPI-Q in individuals with MCI and AD
Aim 2 To assess cognition telephonic version of the Montreal Cognitive Assessment tMoCA12 and daily function Functional Activities Questionnaire FAQ13 Hypothesis The number of COVID-related factors will be positively correlated with the severity of cognitive and functional deficits in individuals with MCI and AD
Aim 3 To explore the associations among COVID-related factors and caregiver distress Hypothesis Caregiver resilience and perceived social support will modify the association between COVID-related factors and severity of distress in caregivers
Detailed Description:
Apathy a profound loss of initiative and motivation is often seen in older Veterans with memory problems Apathy leads to serious health problems increases dependency and caregiver burden If untreated apathy hastens the progression to frank dementia In a pilot study the investigators found that apathy working memory and function can be restored using magnetic stimulation in some but not all older Veterans The reason for this variation is unknown The investigators propose a three-phase study in 125 older Veterans with mild cognitive impairment Their motivation other behavioral problems memory and function will be measured periodically Veterans with apathy that are eligible for treatment will receive either real or sham magnetic stimulation to the dorsolateral prefrontal cortex over 20 daily sessions on consecutive week days Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not Impact on function quality of life and rates of progression to dementia will also be studied
A project modification was obtained to conduct a cross-sectional study the COVID Dementia study The cross-sectional study will examine the effect of the pandemic on MCI and AD patients and their caregivers individual COVID-related factors such as personally infected death of a friendfamily member economic hardship disruption in care isolation barriers to telehealth caregiver distress NPS cognition including onset of delirium and function Our goal is to develop a multi-pronged remotely deliverable intervention to address consequences of healthcare disruptions in older Veterans with cognitive impairment
Aim 1 To explore the association between COVID-related factors and neuropsychiatric symptoms in individuals with MCI and AD Hypothesis The number of COVID-related factors endorsed by caregivers will be positively correlated with the severity of NPI-Q in individuals with MCI and AD
Aim 2 To assess cognition telephonic version of the Montreal Cognitive Assessment tMoCA12 and daily function Functional Activities Questionnaire FAQ13 Hypothesis The number of COVID-related factors will be positively correlated with the severity of cognitive and functional deficits in individuals with MCI and AD
Aim 3 To explore the associations among COVID-related factors and caregiver distress Hypothesis Caregiver resilience and perceived social support will modify the association between COVID-related factors and severity of distress in caregivers
A project modification was obtained to conduct a cross-sectional study the COVID Dementia study The cross-sectional study will examine the effect of the pandemic on MCI and AD patients and their caregivers individual COVID-related factors such as personally infected death of a friendfamily member economic hardship disruption in care isolation barriers to telehealth caregiver distress NPS cognition including onset of delirium and function Our goal is to develop a multi-pronged remotely deliverable intervention to address consequences of healthcare disruptions in older Veterans with cognitive impairment
Aim 1 To explore the association between COVID-related factors and neuropsychiatric symptoms in individuals with MCI and AD Hypothesis The number of COVID-related factors endorsed by caregivers will be positively correlated with the severity of NPI-Q in individuals with MCI and AD
Aim 2 To assess cognition telephonic version of the Montreal Cognitive Assessment tMoCA12 and daily function Functional Activities Questionnaire FAQ13 Hypothesis The number of COVID-related factors will be positively correlated with the severity of cognitive and functional deficits in individuals with MCI and AD
Aim 3 To explore the associations among COVID-related factors and caregiver distress Hypothesis Caregiver resilience and perceived social support will modify the association between COVID-related factors and severity of distress in caregivers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1115904 | OTHER | Central Arkansas Veterans Healthcare System | None |